Remimazolam Has Low Oral Bioavailability and No Potential for Misuse in Drug-Facilitated Sexual Assaults, with or Without Alcohol: Results from Two Randomised Clinical Trials
ConclusionThe oral bioavailability of remimazolam is negligible, which —together with its distinct bitter taste—suggests no meaningful potential for misuse in drug-facilitated sexual assaults via oral ingestion, with or without alcohol.Clinical Trial Registration NumbersTrial 1 (NCT04113564) and trial 2 (NCT04113343) both retrospectively registered on 2 October 2019. (Source: Drugs in R&D)
Source: Drugs in R&D - August 13, 2020 Category: Drugs & Pharmacology Source Type: research

Combined Intravenous Sildenafil and l -Arginine Administration in a Porcine Animal Model: Hemodynamic Safety Profile and Effects on Coronary Blood Flow
ConclusionsThe combined intravenous administration of sildenafil andl-arginine in a porcine animal model was safe, well tolerated, and had at least additive effects on left anterior descending artery blood flow. Simultaneous application of both drugs might have dose-sparing effects leading to desired coronary effects at lower and safer sildenafil andl-arginine plasma concentrations. Hyperosmolality was only a minor factor inl-arginine hemodynamic effects. (Source: Drugs in R&D)
Source: Drugs in R&D - July 27, 2020 Category: Drugs & Pharmacology Source Type: research

Fingolimod as a Treatment in Neurologic Disorders Beyond Multiple Sclerosis
AbstractFingolimod is an approved treatment for relapsing –remitting multiple sclerosis (MS), and its properties in different pathways have raised interest in therapy research for other neurodegenerative diseases. Fingolimod is an agonist of sphingosine-1-phosphate (S1P) receptors. Its main pharmacologic effect is immunomodulation by lymphocyte homing, t hereby reducing the numbers of T and B cells in circulation. Because of the ubiquitous expression of S1P receptors, other effects have also been described. Here, we review preclinical experiments evaluating the effects of treatment with fingolimod in neurodegenerativ...
Source: Drugs in R&D - July 22, 2020 Category: Drugs & Pharmacology Source Type: research

Population Pharmacokinetics of Magnesium Sulfate in Preeclampsia and Associated Factors
ConclusionThe PK of MgSO4 in pregnant women with PE is significantly affected by creatinine and body weight. Pregnant women with PE and higher body weight have a higherV and, consequently, a lower elimination rate of MgSO4. Pregnant women with PE and a higher serum creatinine value show lower CL and, therefore, lower MgSO4 elimination rate. (Source: Drugs in R&D)
Source: Drugs in R&D - July 8, 2020 Category: Drugs & Pharmacology Source Type: research

Pexidartinib (TURALIO ™): The First FDA-Indicated Systemic Treatment for Tenosynovial Giant Cell Tumor
AbstractTenosynovial giant cell tumor is a rare proliferative tumor that arises from the synovium, bursae, or tendon sheaths due to an overproduction of colony-stimulating factor 1. Historically, treatment options for patients with local or diffuse tenosynovial giant cell tumor have been limited to surgical interventions. However, for some patients, surgical resection could worsen functional limitations and/or morbidity. In August 2019, the FDA approved pexidartinib (TURALIO ™, Daiichi Sankyo), the first systemic treatment option for adult patients with symptomatic tenosynovial giant cell tumor associated with severe...
Source: Drugs in R&D - July 2, 2020 Category: Drugs & Pharmacology Source Type: research

Identification of a Potential Peptide Inhibitor of SARS-CoV-2 Targeting its Entry into the Host Cells
ConclusionOur findings suggest that computationally developed inhibitory peptide may be developed as an anti-SARS-CoV-2 agent for the treatment of SARS-CoV-2 infection. We further plan to pursue the peptide in cell-based assays and eventually for clinical trials. (Source: Drugs in R&D)
Source: Drugs in R&D - June 26, 2020 Category: Drugs & Pharmacology Source Type: research

Ex-vivo Sensitivity of Plasmodium falciparum to Common Anti-malarial Drugs: The Case of K éniéroba, a Malaria Endemic Village in Mali
AbstractBackgroundIn 2006, the National Malaria Control Program in Mali recommended artemisinin-based combination therapy as the first-line treatment for uncomplicated malaria. Since the introduction of artemisinin-based combination therapy, few reports are available on the level of resistance ofPlasmodium falciparum to the most common anti-malarial drugs in Mali.MethodsFrom 2016 to 2017, we assessed the ex-vivo drug sensitivity ofP. falciparum isolates in K éniéroba, a village located in a rural area of southern Mali. We collectedP. falciparum isolates from malaria-infected children living in K éni&ea...
Source: Drugs in R&D - June 18, 2020 Category: Drugs & Pharmacology Source Type: research

Cutaneous Adverse Events in Newly Approved FDA Non-cancer Drugs: A Systematic Review
AbstractThe prevalence of cutaneous adverse events attributable to newly approved anti-cancer drugs has been well reviewed in the dermatologic literature. In contrast, over 75% of US Food and Drug Administration approvals in the past 5  years have been for non-cancer drugs and indications. This represents multiple other categories of approved medications associated with cutaneous adverse reactions. To investigate the cutaneous adverse events associated with these potentially neglected medications, a systematic review was conducte d. Two hundred and forty-one medications approved by the Food and Drug Administration bet...
Source: Drugs in R&D - June 17, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study
AbstractIntroductionIbuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug –drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety.ObjectivesThe present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400  mg and placebo.MethodsThis 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200  mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and pla...
Source: Drugs in R&D - June 6, 2020 Category: Drugs & Pharmacology Source Type: research

In-Vitro Sorbent-Mediated Removal of Edoxaban from Human Plasma and Albumin Solution
ConclusionSorbent-mediated technology may represent a viable pathway for edoxaban removal from human plasma or albumin solution. (Source: Drugs in R&D)
Source: Drugs in R&D - May 15, 2020 Category: Drugs & Pharmacology Source Type: research

Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial
This study evaluates IV tramadol in the management of postoperative pain compared to placebo and standard-of-care active control.MethodsA phase 3, multicenter, double-blind, three-arm, randomized, placebo- and active-controlled, multiple-dose, parallel-group study was conducted to evaluate the efficacy and safety of 50  mg IV tramadol versus placebo and 4 mg IV morphine over 48 h in patients with postoperative pain following abdominoplasty surgery.ResultsIV tramadol was statistically superior (p 
Source: Drugs in R&D - May 14, 2020 Category: Drugs & Pharmacology Source Type: research

In Vitro Investigation of Auranofin as a Treatment for Clostridium difficile Infection
ConclusionsAuranofin is highly efficacious againstC. difficile M7404 in vitro and has the potential to be an ideal therapeutic option for the treatment ofC. difficile infection. (Source: Drugs in R&D)
Source: Drugs in R&D - May 6, 2020 Category: Drugs & Pharmacology Source Type: research

Public Health Outcomes May Differ After Switching from Brand-Name to Generic Angiotensin II Receptor Blockers
ConclusionsWe observed an increased risk of hospitalizations for patients switched to generic valsartan, and a decreased risk of death for patients switched to generic candesartan, compared with those who continued taking the brand-name drug. The differences between generic and brand-name drugs may lead to some differences in public health outcomes, but this safety signal must be further studied using other cohorts and settings. (Source: Drugs in R&D)
Source: Drugs in R&D - April 27, 2020 Category: Drugs & Pharmacology Source Type: research

Frequency and Types of Pathological Upper Gastrointestinal Endoscopy Findings in Clinically Healthy Individuals
The objective of this analysis was to characterize the occurrence of pathological findings in the upper gastrointestinal tract in symptom-free healthy individuals.MethodsA baseline EGD was performed in clinically healthy individuals in three clinical trials aimed to assess gastrointestinal tolerability of drugs. Pathological findings were described by type (redness, erosion, ulcer or other), number, size and location, and by clinical relevance as assessed by the endoscopist. Characteristics of volunteers were tested as potential covariates.ResultsA total of 294 EGDs were assessed. Characteristics of individuals were as fol...
Source: Drugs in R&D - April 25, 2020 Category: Drugs & Pharmacology Source Type: research

An Ex Vivo Evaluation of Cenobamate Administered via Enteral Tubes
ConclusionThe mean % LC recovery of cenobamate was within the predetermined acceptable range of 90.0 –110.0%, suggesting no adhesion or adsorption of cenobamate to enteral feeding tubes. Delivery of cenobamate suspension via enteral feeding tubes may be a viable route of administration for patients who cannot swallow tablets. (Source: Drugs in R&D)
Source: Drugs in R&D - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

Combining Isotopic Tracer Techniques to Increase Efficiency of Clinical Pharmacokinetic Trials in Oncology
AbstractWith increasing numbers of drugs tested in oncology for smaller patient populations, fewer patients are available to answer important clinical pharmacological questions in the timeframe of clinical drug development. The quality and efficiency of trials to assess the pharmacokinetics of new drugs can be improved by making better use of available resources. One approach to do this is by making more effective use of isotopic tracer techniques. With increasing sensitivity of liquid chromatography-tandem mass spectrometry analyzing equipment over the years, it has now become possible to generate much more rich, high-qua...
Source: Drugs in R&D - April 16, 2020 Category: Drugs & Pharmacology Source Type: research

Assessment of Vancomycin Pharmacokinetics and Dose Regimen Optimisation in Preterm Neonates
ConclusionThe majority of the neonates were under dosed. Vancomycin 12  mg/kg should be administered every 8 h over 1 h infusion to improve the likelihood of achieving the AUC0 –24h target of ≥ 400 mg × h/L. This target is considered optimal for MRSA infections, where the vancomycin minimum inhibitory concentration is ≤ 1 µg/mL. (Source: Drugs in R&D)
Source: Drugs in R&D - April 8, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of VB-1953 Topical Gel in Non-Responder Acne Patients with Clindamycin-Resistant Cutibacterium acnes
In this study, we investigated the safety, tolerability, and efficacy of VB-1953 topical gel in patients with moderate to severe acne having clindamycin-resistantC. acnes.MethodsAn investigator-initiated, open label, single-arm clinical study was conducted in patients with moderate to severe facial acne vulgaris showing poor or no response to previous clindamycin treatment. Nineteen subjects were enrolled in the study based on laboratory screening for the presence of clindamycin-resistantC. acnes in acne swab samples collected from patients. VB-1953 2% gel was applied on the entire face twice daily over 12  weeks. The...
Source: Drugs in R&D - March 28, 2020 Category: Drugs & Pharmacology Source Type: research

Poly (ADP-Ribose) Polymerase Inhibitors: Talazoparib in Ovarian Cancer and Beyond
AbstractGenetic complexity and DNA damage repair defects are common in different cancer types and can induce tumor-specific vulnerabilities. Poly(ADP-ribose) polymerase (PARP) inhibitors exploit defects in the DNA repair pathway through synthetic lethality and have emerged as promising anticancer therapies, especially in tumors harboring deleterious germline or somatic breast cancer susceptibility gene (BRCA) mutations. However, the utility of PARP inhibitors could be expanded beyond germlineBRCA1/2 mutated cancers by causing DNA damage with cytotoxic agents in the presence of a DNA repair inhibitor. US Food and Drug Admin...
Source: Drugs in R&D - March 25, 2020 Category: Drugs & Pharmacology Source Type: research

Dolutegravir-Based Antiretroviral Regimens for HIV Liver Transplant Patients in Real-Life Settings
ConclusionsThe management of HIV-positive liver transplant recipients in clinical practice is a complex task, where possibility of simplifying antiretroviral regimens must be balanced with the need to guarantee optimal immunosuppression and the finest treatment tolerability. A multidisciplinary approach involving physicians and clinical pharmacologists/pharmacists could help achieve this goal. (Source: Drugs in R&D)
Source: Drugs in R&D - March 18, 2020 Category: Drugs & Pharmacology Source Type: research

Concordance of Vancomycin Population-Predicted Pharmacokinetics with Patient-Specific Pharmacokinetics in Adult Hospitalized Patients: A Case Series
The objective of this study is to assess the correlational fit between vancomycin population-predicted and patient-specific pharmacokinetic parameters [elimination rate constant (Ke) and half-life (t1/2)] in a case series of adult hospitalized patients.MethodsThis is a single-center case series of hospitalized adult patients who received vancomycin, had creatinine clearance calculation for derivation of population-predicted pharmacokinetic parameters, and had two vancomycin concentrations for calculation of patient-specific pharmacokinetic parameters. The primary objective of this case series is to evaluate the correlation...
Source: Drugs in R&D - March 12, 2020 Category: Drugs & Pharmacology Source Type: research

Plasma Polyethylene Glycol (PEG) Levels Reach Steady State Following Repeated Treatment with N8-GP (Turoctocog Alfa Pegol; Esperoct ® )
ConclusionSteady-state PEG levels were reached in plasma from rats and humans repeatedly treated with N8-GP. No unexpected increase in PEG was observed. (Source: Drugs in R&D)
Source: Drugs in R&D - March 9, 2020 Category: Drugs & Pharmacology Source Type: research

Phase I Pharmacokinetic Study of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in Healthy Adult and Adolescent Populations
ConclusionsThe FDC of ibuprofen/acetaminophen 250/500  mg has a PK profile similar to its monocomponent constituents when administered separately or coadministered, indicating no drug–drug interactions and no formulation effects. Similar to previous findings for the individual components, the rates of absorption of ibuprofen and acetaminophen from t he FDC were slightly delayed in the presence of food. Overall, adolescents had similar exposures to acetaminophen and ibuprofen as adults, while younger adolescents had slightly greater exposure than older adolescents, probably due to their smaller body size. The FDC...
Source: Drugs in R&D - March 4, 2020 Category: Drugs & Pharmacology Source Type: research

Intramuscular Clodronate in Long-Term Treatment of Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
ConclusionOur study indicates that intramuscular administration of a therapeutic dose of clodronate followed by a maintenance dose is effective in the management of symptomatic knee osteoarthritis, improving functional outcomes and reducing pain and bone marrow edema. Prolonged treatment increases the long-term efficacy of clodronate compared with the shorter schedule. (Source: Drugs in R&D)
Source: Drugs in R&D - February 20, 2020 Category: Drugs & Pharmacology Source Type: research

Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome
ConclusionsFurther investigations are necessary to better evaluate the potential cognitive-enhancing role of intranasal insulin in the Down syndrome population.ClinicalTrials.gov IDNCT02432716. (Source: Drugs in R&D)
Source: Drugs in R&D - February 19, 2020 Category: Drugs & Pharmacology Source Type: research

Prediction of Clearance in Children from Adults Following Drug –Drug Interaction Studies: Application of Age-Dependent Exponent Model
ConclusionThis study indicates that it is possible to predict the clearance of drugs with reasonable accuracy in children from adults following DDI studies using an ADE model. The method is simple, robust, and reliable and can replace other complex empirical models. (Source: Drugs in R&D)
Source: Drugs in R&D - February 13, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of Fosphenytoin Therapeutic Drug Monitoring in the Neurocritical Care Unit
ConclusionThe current method of calculating a fosphenytoin reloading dose in the critically ill population does not consistently result in therapeutic concentrations. With multiple factors affecting the pharmacokinetics of critically ill patients, the creation of a new pharmacokinetic model with less emphasis on volume of distribution may more consistently result in therapeutic concentrations. (Source: Drugs in R&D)
Source: Drugs in R&D - January 10, 2020 Category: Drugs & Pharmacology Source Type: research

Extrapolation of Drug Clearance in Children ≤ 2 Years of Age from Empirical Models Using Data from Children ( & gt;  2 Years) and Adults
ConclusionsThe study indicated that simple empirical models can provide more accurate results than complex empirical models. (Source: Drugs in R&D)
Source: Drugs in R&D - December 9, 2019 Category: Drugs & Pharmacology Source Type: research

The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A
ConclusionThe results demonstrated that turoctocog alfa can be subjected to variable storage conditions, including cycling between 5  °C and ≤ 40 °C, and subsequent storage for 3 months up to 40 °C, without loss of stability. This suggests that turoctocog alfa may offer greater product storage flexibility for patients in everyday practice, with a potential reduction in wastage. (Source: Drugs in R&D)
Source: Drugs in R&D - November 28, 2019 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drugs in R&D)
Source: Drugs in R&D - November 20, 2019 Category: Drugs & Pharmacology Source Type: research

Use of Selective Serotonin Reuptake Inhibitors and Outcomes in Stroke Rehabilitation: A Prospective Observational Pilot Cohort Study
ConclusionSSRI therapy did not improve disability and QOL in multi-ethnic Asian patients with first-ever stroke undergoing rehabilitation. (Source: Drugs in R&D)
Source: Drugs in R&D - November 18, 2019 Category: Drugs & Pharmacology Source Type: research

A Clinician ’s Guide to the Recognition and Management of Dupilumab-Associated Conjunctivitis
AbstractDupilumab, a monoclonal antibody that inhibits both interleukin (IL)-4 and IL-13 signaling, is an effective treatment option in moderate-to-severe atopic dermatitis (AD). Patients with AD are already at increased risk of developing conjunctivitis, and clinical trials and case reports have shown a greater incidence of conjunctivitis in individuals with AD treated with dupilumab. As this is one of the more commonly reported side effects of this biologic agent, it is important that clinicians are aware of this association and advise patients receiving dupilumab to report signs of conjunctivitis. This review summarizes...
Source: Drugs in R&D - November 14, 2019 Category: Drugs & Pharmacology Source Type: research

The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study
ConclusionsVidofludimus demonstrated a positive safety profile, making it a promising candidate for the treatment of a variety of immune-related diseases.Trial RegistrationsClinicalTrials.gov identifier: NCT01010581. (Source: Drugs in R&D)
Source: Drugs in R&D - October 16, 2019 Category: Drugs & Pharmacology Source Type: research

Are Standard Doses of Renally-Excreted Antiretrovirals in Older Patients Appropriate: A PBPK Study Comparing Exposures in the Elderly Population With Those in Renal Impairment
ConclusionComparison of the exposure in the elderly with exposure observed in patients with different levels of renal impairment, indicated that a dosage adjustment may not be required in elderly patients on lamivudine, emtricitabine and the majority of the patients on tenofovir. Clinical trials to verify these predictions are essential. (Source: Drugs in R&D)
Source: Drugs in R&D - October 10, 2019 Category: Drugs & Pharmacology Source Type: research

Apremilast Normalizes Gene Expression of Inflammatory Mediators in Human Keratinocytes and Reduces Antigen-Induced Atopic Dermatitis in Mice
ConclusionPDE4 is overexpressed in AD skin compared with normal skin, and inflammatory gene expression by human keratinocytes and mouse dermatitis can be modulated by apremilast. (Source: Drugs in R&D)
Source: Drugs in R&D - October 9, 2019 Category: Drugs & Pharmacology Source Type: research

Prediction of Drug –Drug Interactions Between Opioids and Overdosed Benzodiazepines Using Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation
ConclusionOur results appear to indicate that pharmacodynamics may play a more important role than PKs in causing DDIs between opioids and benzodiazepines. This study also demonstrated that molecular modeling can be a very useful tool to mitigate the problem of “missing metabolic reaction parameters” in PK modeling and simulation. (Source: Drugs in R&D)
Source: Drugs in R&D - September 3, 2019 Category: Drugs & Pharmacology Source Type: research

Characterization of the Pharmacokinetics of Samidorphan in Healthy Volunteers: Absolute Bioavailability and the Effect of Food and Age
ConclusionsSAM has high bioavailability that is comparable following sublingual and oral administration and is not subject to extensive first-pass metabolism. The PK of orally administered SAM are not affected by food or age. (Source: Drugs in R&D)
Source: Drugs in R&D - August 29, 2019 Category: Drugs & Pharmacology Source Type: research

Vasodepressor Effects of Adenosine in the Cat are Independent of Cyclooxygenase, Potassium Channels, and Nitric Oxide Pathways
ConclusionsVasodepressor effects of adenosine are species specific, and this species specificity will impact the development of future testing and treatments for pulmonary arterial hypertension. Clinical studies are warranted to see if adenosine moieties could play a therapeutic role in patients with pulmonary arterial hypertension and/or other pulmonary pathogeneses. (Source: Drugs in R&D)
Source: Drugs in R&D - August 26, 2019 Category: Drugs & Pharmacology Source Type: research

Amount of Cycloserine Emanating from Terizidone Metabolism and Relationship with Hepatic Function in Patients with Drug-Resistant Tuberculosis
ConclusionsCycloserine is not interchangeable with terizidone, as amounts are lower than expected. Cycloserine may be a predisposing factor to the development of hyperbilirubinaemia, as CLm/F is affected by hepatic function. (Source: Drugs in R&D)
Source: Drugs in R&D - August 8, 2019 Category: Drugs & Pharmacology Source Type: research

Correction to: Safety and Efficacy of 0.5% Carbomer 980 Gel for Treatment of Symptoms of Common Cold: Results of 2 Randomized Trials
The original publication of the article contained the following errors. (Source: Drugs in R&D)
Source: Drugs in R&D - July 20, 2019 Category: Drugs & Pharmacology Source Type: research

Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab
ConclusionsThis analysis has confirmed a prognostic effect of primary tumour location in patients withRAS wild-type metastatic colorectal cancer receiving first-line panitumumab plus FOLFIRI. Early tumour shrinkage was associated with improved progression-free survival irrespective of tumour location. In right-sided disease, early tumour shrinkage may identify a subgroup of patients who might respond to panitumumab.ClinicalTrials.gov identifierNCT00508404. (Source: Drugs in R&D)
Source: Drugs in R&D - July 12, 2019 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics of Sublingual Buprenorphine Tablets Following Single and Multiple Doses in Chinese Participants With and Without Opioid Use Disorder
ConclusionsThe present data suggest that buprenorphine/naloxone pharmacokinetic profiles in Chinese participants are consistent, overall, with those in Western populations, supporting no differences in dosing.Clinical Trial RegistrationThe protocols were registered on the official website of the China Food and Drug Administration (CFDA):http://www.chinadrugtrials.org.cn/; Registration numbers CTR20132963 (RB-CN-10-0012), CTR20140153 (RB-CN-10-0015). (Source: Drugs in R&D)
Source: Drugs in R&D - June 13, 2019 Category: Drugs & Pharmacology Source Type: research

Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets
AbstractIntroductionSublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population.MethodsWe performed subgroup analyses of a recently completed trial in two subsets of individuals: patients aged 65 –74 years (low age group) and patients ≥ 75 years (high age group). Pain intensity (PI), onset of pain relief, frequency and...
Source: Drugs in R&D - June 8, 2019 Category: Drugs & Pharmacology Source Type: research

Elderly Bleeding Risk of Direct Oral Anticoagulants in Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Cohort Studies
AbstractIntroductionThe 2014 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines recommend anticoagulation to reduce clot formation and the risk of thromboembolic events in patients with atrial fibrillation but does not specify guidelines for the elderly population. Direct oral anticoagulants (DOACs) are newer US FDA-approved alternatives to warfarin and include dabigatran, rivaroxaban, apixaban and edoxaban. The efficacy of DOACs is heavily researched, but few studies have evaluated their bleeding risk.ObjectivesThis systematic review and meta-analysis investigates w...
Source: Drugs in R&D - May 24, 2019 Category: Drugs & Pharmacology Source Type: research

Timing of GLP-1 Receptor Agonist Initiation for Treatment of Type 2 Diabetes in the UK
ConclusionsResults suggest that treatment intensification is often delayed despite consistently poor glycaemic control for more than 12  months, contrary to treatment guideline recommendations. Findings from this study highlight that some T2DM patients may benefit from more rapid treatment intensification, which could improve glycaemic control and reduce the risk for many short- and long-term health complications. (Source: Drugs in R&D)
Source: Drugs in R&D - May 21, 2019 Category: Drugs & Pharmacology Source Type: research

Neuropsychiatric Symptoms in Dementia: Considerations for Pharmacotherapy in the USA
AbstractDementia affects all domains of cognition. The relentless progression of the disease after diagnosis is associated with a 98% incidence of neuropsychiatric symptoms (NPS) at some point in the disease, including depression, psychosis, agitation, aggression, apathy, sleep disturbances, and disinhibition. These symptoms can be severe and lead to excess morbidity and mortality. The purpose of this article was to describe current literature on the medication management of NPS of dementia and highlight approaches to and concerns about the pharmacological treatment of NPS in the USA. Guidelines and expert opinion favor no...
Source: Drugs in R&D - May 16, 2019 Category: Drugs & Pharmacology Source Type: research

Towards a Generic Tool for Prediction of Meropenem Systemic and Infection-Site Exposure: A Physiologically Based Pharmacokinetic Model for Adult Patients with Pneumonia
ConclusionsWe successfully developed a physiologically based pharmacokinetic model for meropenem in adult patients to be used as a basis for prediction of concentrations in different groups of patients, and eventually for effective dose individualisation in different subgroups of the population. (Source: Drugs in R&D)
Source: Drugs in R&D - May 14, 2019 Category: Drugs & Pharmacology Source Type: research

A Novel, Dose-Adjusted Tacrolimus Trough-Concentration Model for Predicting and Estimating Variance After Kidney Transplantation
ConclusionThis is the first known application of a functional regression model to assess complex relationships between TTC and dose in a real clinical setting. This new method has applicability in future clinical trials including real-world data sets due to flexibility of the nonparametric modeling approach. (Source: Drugs in R&D)
Source: Drugs in R&D - May 9, 2019 Category: Drugs & Pharmacology Source Type: research

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis
ConclusionsThe efficacy and safety of NOACs as thromboprophylaxis for AF and VHD are similar to those of warfarin. (Source: Drugs in R&D)
Source: Drugs in R&D - May 4, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Efficacy of 0.5% Carbomer 980 Gel for Treatment of Symptoms of Common Cold: Results of 2 Randomized Trials
ConclusionWhile 0.5% carbomer 980 gel nasal spray demonstrated good local nasal tolerability in healthy volunteers, the spray did not significantly impact the course of infection or resolution of cold symptoms in subjects with common cold. (Source: Drugs in R&D)
Source: Drugs in R&D - April 19, 2019 Category: Drugs & Pharmacology Source Type: research